| CTRI Number |
CTRI/2025/11/097990 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing different ways of cleaning the viscoelastic substance from the eyes of patients during cataract surgery to improve the safety and recovery of patients admitted for cataract surgery |
|
Scientific Title of Study
|
A Randomised Controlled Trial Comparing the Outcomes of Different Irrigation-Aspiration Techniques for Viscoelastic Removal in Cataract Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUNKARA VENKATA MAHALAKSHMI |
| Designation |
1ST YEAR POSTGRADUATE |
| Affiliation |
ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, ELURU |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
OPD NO -115
ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, ELURU
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
|
| Fax |
|
| Email |
mahalakshmi27299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
U VIVEKANAND |
| Designation |
HOD AND PROFESSOR, DEPARTMENT OF OPHTHALMOLOGY |
| Affiliation |
ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, ELURU |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
OPD NO -115
ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, ELURU
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
8333044920 |
| Fax |
|
| Email |
vivekanandu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUNKARA VENKATA MAHALAKSHMI |
| Designation |
1ST YEAR POSTGRADUATE |
| Affiliation |
ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, ELURU |
| Address |
DEPARTMENT OF OPHTHALMOLOGY
OPD NO -115
ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, ELURU
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
9398235615 |
| Fax |
|
| Email |
mahalakshmi27299@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, MALKAPURAM, ELURU |
|
|
Primary Sponsor
|
| Name |
SUNKARA VENKATA MAHALAKSHMI |
| Address |
1ST YEAR POSTGRADUATE
DEPARTMENT OF OPHTHALMOLOGY
ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, MALKAPURAM, ELURU |
| Type of Sponsor |
Other [SLEF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SUNKARA VENKATA MAHALAKSHMI |
ALLURI SITARAMARAJU ACADEMY OF MEDICAL SCIENCES, ELURU |
DEPARTMENT OF OPHTHALMOLOGY
OPD NO-II5
West Godavari
ANDHRA PRADESH |
9398235615
mahalakshmi27299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ASRAMS BHR ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H598||Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified, (2) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
REMOVAL OF VISCOELASTIC SUBSTANCE TECHNIQUE DURING PHACOEMULSIFICATION |
Technique A: Aspiration from the anterior chamber along with IOL tapping
Technique B: Active aspiration behind the IOL using an irrigation and aspiration (I/A) probe while maintaining capsular integrity.
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Nuclear sclerosis grade II—III (Lens Opacities Classification System III)
Normal axial length (21.5—24.5 mm)
No prior ocular surgery
Follow up patients
|
|
| ExclusionCriteria |
| Details |
Patients lost to follow-up
Patients with Glaucoma, Corneal opacity, or dystrophy
History of uveitis, trauma
Pseudo-exfoliation or zonular instability
Patients with poor pupil dilation -less than 6mm
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Measurement of
1.Intraocular pressure (IOP),
2 Intraocular Lens Position (IOLP) using anterior segment imaging.
3.Refractive outcomes-the spherical equivalent (SE)
4.Anterior chamber (AC) depth changes over the first 6 weeks post-surgery between the two groups.
|
Day 1, Week 1, Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Title A Randomized Controlled Trial Comparing the Outcomes of Different Irrigation-Aspiration Techniques for Viscoelastic Removal in Cataract Surgery
Introduction Ophthalmic viscoelastic devices (OVDs) are essential in cataract surgery to maintain anterior chamber depth, protect intraocular structures, and facilitate intraocular lens (IOL) implantation. Incomplete OVD removal, especially behind the IOL in the retrolental space, may cause postoperative complications like intraocular pressure (IOP) spikes, capsular block syndrome (CBS), and unintended refractive shifts.
Techniques Compared - *Technique A:* Aspiration from the anterior chamber with IOL tapping. - *Technique B:* Active aspiration behind the IOL using an irrigation and aspiration (IA) probe while maintaining capsular integrity.
Aim To compare the efficiency and outcomes of these two IA techniques in OVD removal during phacoemulsification cataract surgery.
Study Design - Prospective, double-blinded, randomized controlled trial. - Total sample size: 126 patients (63 in each group). - Single experienced surgeon performing all surgeries under standardized conditions. - Follow-up at Day 1, Week 1, and Week 6 postoperatively. - Outcomes measured: IOP, IOL position (anterior segment imaging), spherical equivalent refractive outcomes, anterior chamber depth changes.
Inclusion Criteria - Age 50–80 years. - Nuclear sclerosis grade II–III (LOCS III classification). - Normal axial length 21.5–24.5 mm. - No prior ocular surgery. - Willingness to follow up.
Exclusion Criteria - Glaucoma or ocular hypertension. - Pseudoexfoliation syndrome or zonular instability. - Corneal dystrophies or opacities. - Poor pupil dilation <6 mm. - History of uveitis or ocular trauma. - Patients lost to follow-up.
Ethics - Institutional ethical approval obtained. - Adherence to Declaration of Helsinki. - Informed consent obtained from all participants.
This trial aims to provide evidence-based guidance on the best irrigation-aspiration technique to reduce postoperative complications and improve visual outcomes after cataract surgery |